Visitor Monitoring Drug History: ZINACEF
 
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Label and Approval History

Drug Name: ZINACEF
FDA Application No: (NDA) 050558
Active Ingredient(s): CEFUROXIME SODIUM
Company: GLAXOSMITHKLINE
 
Label History
 
View the label approved on July 31, 2007 for ZINACEF, (NDA) 050558


To see older, previously-approved labels, go to the "Approval History" section of this page. Older labels are for historical information only and should not be used for clinical purposes.
 
 
 
Approval History
 
Action DateSupplement NumberSort imageApproval TypeLetters, Reviews, Labels, Patient Package Insert
7/30/2007 067Labeling Revision Letter
Label 
5/19/2004 057Labeling Revision Letter
Label 
10/23/2002 054Control Supplement  
11/9/2001 053Control Supplement  
5/5/2001 052Control Supplement  
4/13/2001 051Control Supplement  
10/12/2001 050Labeling Revision Label 
7/12/2001 049Labeling Revision  
4/3/1997 048Manufacturing Change or Addition  
12/23/1996 047Labeling Revision  
10/31/1995 046Manufacturing Change or Addition  
9/11/1996 045Labeling Revision  
12/23/1996 044Labeling Revision  
9/29/1995 043Labeling Revision  
6/28/1993 042Control Supplement  
10/27/1994 041Labeling Revision  
12/31/1992 040Labeling Revision  
2/6/1995 037Labeling Revision  
2/18/1993 036Manufacturing Change or Addition  
9/23/1992 035Control Supplement  
8/14/1991 033Manufacturing Change or Addition  
2/13/1992 032Package Change  
10/23/1995 031Labeling Revision  
11/4/1992 030Control Supplement  
2/13/1992 029Control Supplement  
2/13/1992 028Control Supplement  
3/22/1990 027Manufacturing Change or Addition  
6/30/1989 026Labeling Revision  
3/24/1989 025Control Supplement  
9/25/1987 024Package Change  
8/28/1987 023Labeling Revision  
8/13/1987 022Manufacturing Change or Addition  
5/12/1988 020Labeling Revision  
10/23/1986 019Labeling Revision  
5/30/1986 018Control Supplement  
4/17/1986 017Package Change  
1/23/1986 015Package Change  
11/25/1985 013Manufacturing Change or Addition  
4/3/1985 012Manufacturing Change or Addition  
7/27/1984 010Control Supplement  
8/20/1984 009Manufacturing Change or Addition  
5/11/1984 008Labeling Revision  
4/18/1984 007Labeling Revision  
3/5/1984 006Labeling Revision  
2/17/1984 005Labeling Revision  
2/8/1984 004Manufacturing Change or Addition  
12/22/1983 002Labeling Revision  
12/7/1983 001Labeling Revision  
10/19/1983 000Approval  
 
Therapeutic Equivalents
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